Skin Substitute Access and Payment Reform Act

Bill Number: H.R. 5768
Origin Chamber: House
Congress: 119th Congress, Session 1
Policy Area: Health
Status: Introduced
Latest Action: 2025-10-17: Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Last Updated: 2026-06-11T23:26:37Z

AI-Generated Summary

Purpose of the Legislation

The "Skin Substitute Access and Payment Reform Act" (H.R. 5768) aims to improve Medicare coverage and payment for skin substitute products—materials used to treat wounds—by standardizing payments, ensuring access, and strengthening safeguards against fraud or overuse. It seeks to balance cost control with reliable availability for patients needing these treatments for chronic or severe wounds.

Key Provisions

Coverage Expansion: Adds skin substitute products to the list of covered Medicare services under Section 1861(s)(2) of the Social Security Act, defining them as cellular, tissue-based, biological, or synthetic materials applied to wounds to stay in place and promote healing. Excludes temporary dressings or liquid/gel forms.
Payment Reforms:
Starting January 1, 2026, payments will use a new system under Section 1847A, based on a volume-weighted average of 2023 Medicare payment limits (from the Average Sales Price Pricing File), calculated by weighting payments by usage volume.
Annual updates from 2027 onward will adjust payments by the Consumer Price Index for All Urban Consumers (a measure of inflation).
Medicare will pay 80% of the lesser of the actual charge or this new payment amount.
Creates a single new billing and payment code for all such products by January 1, 2026.
Excludes these products from certain drug/biological reporting requirements starting in 2026.
Program Integrity Measures (under new Section 1834(aa)):
Outlier Provider Identification: By December 1, 2025, and every two years through 2035, the Secretary of Health and Human Services (HHS) will identify the top 3% of providers by total Medicare payments for these products in the prior year. This list will be public and shared with the HHS Inspector General for fraud checks.
Prepayment Review: From January 1, 2026, claims from outlier providers undergo review before payment, unless they meet exemptions (e.g., high approval rates over 90%, consistent billing, or prior authorization).
Prior Authorization: Starting January 1, 2027, outlier providers need approval before providing these products; this ends if approval rates exceed 90%. Funds $5 million annually (2027–2030) from the Medicare trust fund to implement.
Enrollment Actions: From January 1, 2028, if denial rates for prior authorizations exceed 75% for six+ months, providers face potential revocation of Medicare billing privileges or exclusion from federal health programs.
2026 Coverage Rules: All qualifying products are covered unless proven unsafe (e.g., due to contamination or serious side effects). No denials based solely on clinical evidence analysis during prepayment or prior authorization in 2026.

Significant Changes to Existing Law

Payment Shift: Moves skin substitute products from variable, code-specific payments (often treated like drugs or biologics) to a uniform, inflation-adjusted system based on historical 2023 data, potentially simplifying billing but capping reimbursements.
New Integrity Framework: Introduces targeted oversight for high-volume providers, including mandatory reviews and authorizations, which did not previously exist specifically for these products. This builds on general Medicare fraud rules but adds product-specific triggers.
Coverage Clarification: Explicitly defines and covers these products, removing ambiguity, while limiting 2026 denials to safety issues only, overriding broader clinical reviews.

Potential Impacts

On Government Agencies: The Centers for Medicare & Medicaid Services (CMS) must develop new codes, conduct reviews, and manage authorizations, increasing administrative workload but supported by dedicated funding. HHS Inspector General gains referrals for audits, potentially reducing fraud-related losses.
On Citizens (Medicare Beneficiaries): Improves access to wound treatments for conditions like diabetes or burns by ensuring coverage and standardized payments, but outlier provider restrictions could temporarily limit options if providers face delays or exclusions. Overall, aims to prevent overbilling that might raise costs.
On International Relations: No direct impacts, as this is a domestic Medicare policy.
Broader Effects: Could lower Medicare spending on these products through controlled payments and fraud prevention, while promoting fair competition among manufacturers.

Main Stakeholders Affected

Medicare Beneficiaries: Patients with chronic wounds who rely on these products for healing.
Healthcare Providers: Wound care specialists, clinics, and hospitals—especially high-volume "outlier" ones—facing new reviews, authorizations, and potential exclusions.
Manufacturers and Suppliers: Companies producing skin substitutes, benefiting from guaranteed coverage but subject to uniform pricing that may reduce profits from high-cost items.
Government Entities: CMS (implementation and oversight), HHS Inspector General (fraud investigations), and Congress (via trust fund transfers).

Notable Legal, Constitutional, or Political Implications

Legal: Strengthens Medicare's fraud-fighting tools under existing authorities (e.g., billing revocation per federal regulations), but the 2026 coverage limits could face challenges if seen as restricting CMS's discretion on medical necessity. Ensures compliance with FDA marketing rules for product definitions.
Constitutional: No apparent issues; aligns with Congress's spending power over federal programs like Medicare.
Political: Bipartisan introduction (sponsors from both parties) highlights focus on healthcare efficiency and anti-fraud in an aging population. May set precedent for similar reforms in other Medicare-covered biologics, influencing future budget debates on program integrity versus access.

This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.

Sponsor

Rep. Carter, Earl L. "Buddy" [R-GA-1]

Cosponsors (7)

Rep. Veasey, Marc A. [D-TX-33], Rep. Steube, W. Gregory [R-FL-17], Rep. McCormick, Richard [R-GA-7], Rep. Hunt, Wesley [R-TX-38], Rep. Vindman, Eugene Simon [D-VA-7], Rep. Ciscomani, Juan [R-AZ-6], Rep. Bice, Stephanie I. [R-OK-5]

Recent Actions

2025-10-17: Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
2025-10-17: Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
2025-10-17: Introduced in House
2025-10-17: Introduced in House

Bill Versions

Skin Substitute Access and Payment Reform Act — issued 2025-10-17 — PDF (13 pages)